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RECRUITING
NCT06139107
PHASE1

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Sponsor: Mridula George, MD

View on ClinicalTrials.gov

Summary

This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.

Official title: RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer

Key Details

Gender

FEMALE

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-08-22

Completion Date

2032-09-30

Last Updated

2025-11-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

Abemaciclib

150mg twice a day for 3 cycles prior to radiation.

DRUG

Letrozole

Letrozole 2.5mg daily

Locations (4)

RWJBarnabas Health Clara Maas Medical Center

Belleville, New Jersey, United States

Cooperman Barnabas Medical Center

Livingston, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States